India Preclinical CRO Market Size, Share & Trends Analysis Report By Service (Toxicology Testing), By Model Type, By End-use (Biopharmaceutical Companies, Government & Academic Institutes), And Segment Forecasts, 2024 - 2030

Market Size & Trends

The India preclinical CRO market size was estimated at USD 183.3 million in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 11.4% from 2024 to 2030. The market growth can be attributed to the increasing trends of outsourcing and R&D in clinical trials worldwide, rising technological advancements, the presence of a significant patient base, a substantial number of hospitals, and low operating expenses due to accessible and skilled human resources. According to the World Health Organization, there were 9,954 clinical trials occurred in India in 2022.

The growing outsourcing of research and development (R&D) activities worldwide is driving the Indian preclinical CRO market. Companies worldwide, including pharmaceuticals, biotechnology, medical devices, and agrochemicals, are leveraging CRO expertise to conduct preclinical studies. This allows pharmaceutical companies to outsource certain aspects of their R&D activities while focusing on core competencies. India is emerging as a key destination due to its skilled workforce, cost advantages, and regulatory environment.

The increasing R&D expenditure worldwide has further propelled the growth of India's preclinical CRO market, as multinational pharmaceutical and biotechnology firms continue leveraging India's resources and expertise to advance their drug development pipelines. According to a study on the CRO sector in India in August 2023 by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers Government of India, the aggregate R&D expenditure of the largest pharmaceutical corporations in 2022 exceeded USD 138 billion, up 1.7% from 2021.

The adoption of cutting-edge technologies such as high-throughput screening, in silico modeling, and advanced imaging techniques have significantly enhanced the capabilities and boosted the growth of preclinical CROs in India. These technologies have expedited the processes involved in drug discovery and development, making it possible to identify possible drug candidates more quickly and accurately. Furthermore, preclinical research efficiency has grown, and experiment turnaround times have decreased due to automation and robotics. For instance, in August 2023, India unveiled its first magnetic resonance imaging (MRI) scanner developed within the country. Voxelgrids Innovations Private Limited, a Bengaluru-based startup, created the portable, lightweight, next-generation MRI scanner for clinical use under the National Biopharma Mission.

The Indian preclinical CRO market is fueled by a large patient base, a vast network of hospitals, and low operating expenses due to accessible and skilled human resources. The large population and enormous healthcare infrastructure enable efficient and cost-effective research. India's low operating expenses are primarily due to the availability of skilled professionals, including doctors and researchers, who contribute to the efficiency and quality of preclinical CRO research. According to the National Medical Commission (NMC), as of June 2022, 13,08,009 allopathic doctors were registered with the NMC and the State Medical Councils.

Market Concentration & Characteristics

Market growth stage is high, and pace of the market growth is accelerating. The market is characterized by a high degree of innovation owing to rapid technological advancements, specifically in areas such as bioinformatics, automation, and high-throughput screening. Advancements in preclinical research have resulted in increased efficacy, precision, and economy of cost.

The market is also characterized by a high level of merger and acquisition (M&A) activity by the leading players. This is due to large CROs acquiring smaller, specialized CROs to broaden their therapeutic expertise, geographic reach, or service offerings and build comprehensive CROs capable of offering end-to-end solutions to pharmaceutical, biotech, and medical device industries. For instance, In February 2020, Eurofins Advinus acquired Gomti Life Sciences Private Limited's entire asset portfolio via a Business Transfer Agreement.

The market is also subject to high regulatory scrutiny. Clinical development is the most regulated phase of the drug development process, as it involves testing on human subjects. Global guidelines known as ICH-GCP norms are followed during clinical trials to ensure clinical trial participants' safety, rights, and well-being. Before approving clinical studies or new drug applications, regulatory agencies frequently demand thorough documentation, data analysis, and review procedures. In India, the regulatory framework governing preclinical research and CROs is overseen by the Central Drugs Standard Control Organization (CDSCO).

There are a limited number of direct service substitutes for preclinical CROs. CROs are essential to pharmaceutical businesses because they aid them with clinical trials, data management, regulatory compliance, and post-marketing surveillance, among other aspects of drug development. The infrastructure, regulatory knowledge and specialized expertise offered by CROs make it difficult for competitors to replicate their all-inclusive services.

The end user concentration in preclinical CROs can be considered high. This is because the primary users of preclinical CROs usually consist of a relatively small number of major pharmaceutical and biotechnology businesses. These companies often outsource their preclinical research activities to specialized CROs, resulting in the end users of preclinical CRO services being concentrated.

Service Insights

Based on service, the toxicology testing segment led the market with the largest revenue share of 22.5% in 2023. This can be attributed to the increased use of toxicity testing and the outsourcing of non-core preclinical CRO research. Toxicology tests are one of the key services performed by CROs owing to their improved capabilities is toxicology tests. The rising rate of outsourcing to CROs for non-core preclinical research and the growing capability of CROs to offer additional value-added services are expected to fuel the growth of this segment during the forecast period.

The bioanalysis and DMPK studies segment are expected to register the fastest CAGR during the forecast period. The mainfactors driving the bioanalysis and DMPK market are technological developmentsin analytical techniques, increased R&D in the pharmaceutical sector, theshift to personalized medicine, strict regulatory requirements, and the risingincidence of chronic illnesses. Furthermore, DMPK studies and bioanalysis areessential to developing new drugs and must be conducted throughout the process, contributing to the segment's growth.

Model Type Insights

Based on model type, the patient derived organoid (PDOs) segment accounted for the largest market revenue share in 2023 and is expected to register the fastest CAGR during the forecast period. PDO models are becoming increasingly crucial in preclinical research since they are highly facile to culture and offer a versatile tool for studying various disorders, including cancer. Moreover, the specimens can be cryopreserved, aiding in tailored healthcare.

In April 2023, InSphero AG announced the signing of a distribution agreement with Bionova Supplies to provide researchers in the Indian market with their patented Akura 96 and 384 Spheroid Microplates. These microplates are designed explicitly for lossless spheroid/organoid formation, handling, and reliable culturing and analysis.

End-use Insights

Based on end-use, the biopharmaceutical companies segment dominated the market in 2023. The biopharmaceutical industry's growing tendency of outsourcing end-to-end services, particularly for small and mid-sized businesses that lack enough preclinical drug development experience, is predicted to increase demand for preclinical CRO services in the coming years.

The government and academic institutes sector is projected to grow at the fastest CAGR over the forecast period. The government and academic institutes segment significantly influences the dynamics of the preclinical CRO market in India. Their collaborative efforts, support for research initiatives, regulatory compliance measures, and contribution to scientific expertise collectively contribute to the growth and development of this sector. Additionally, rising number of government bodies and academic organizations outsourcing preclinical services to CROs is expected to propel the growth of this segment.Many research institutes in India, including Central Drug Research Institute in Lucknow, Central Drug Research Institute, Central Council of Research in Ayurvedic Sciences in Delhi, Indian Institute of Technology Mumbai, CSIR- Indian Institute of Chemical Technology, and, Indian Institute of Integrative Medicine, Jammu outsource clinical trials and some preclinical studies to CROs in India.

Pune, Maharashtra Preclinical CRO Market Trends

The pharmaceutical industry in Pune, Maharashtra, has been witnessing significant growth over the years as pharmaceutical sector expands, the demand for preclinical (CROs) also increases to support drug discovery and development processes. For instance, in July 2022, TCG Lifesciences Pvt. Ltd. unveiled its new R&D facility in Pune, as part of a strategic expansion initiative.

Hyderabad, Telangana Preclinical CRO Market Trends

The collaborative ecosystem in Hyderabad plays a vital role in driving the market growth. CROs in the region often collaborate with academic institutions, research organizations, and industry partners to leverage expertise, resources, and networks for innovative research projects. For instance, In July 2023, GVRP, a preclinical CRO in Hyderabad, announced a partnership with SenzaGen. This strategic alliance establishes GVRP as the official distributor of SenzaGen's GARD Assay services in India, marking the introduction of innovative safety evaluation methods in the region.

Key India Preclinical CRO Company Insights

Some of the key players operating in the market include Syngene International Limited; Dabur Research; JSS Medical Research, and Jubilant Biosys Ltd.

• Syngene International Limited is based in Bangalore. It offers a wide range of services, including medicinal chemistry, biology, toxicology, and other preclinical research services. Syngene has state-of-the-art facilities and a strong track record of collaborations with global pharmaceutical companies

• Dabur Research Foundation is an Indian contract research organization providing preclinical drug research and development services, from identifying potential lead molecules and drug development to IND-enabling studies. It offers preclinical services to the global fields of biotechnology, medicine, phytopharmaceuticals, cosmetics, and science. Its services are broadly divided into functional areas: in vitro, ex vivo, and in vivo pharmacology, research, GLP toxicology, and DMPK

Sugen Life Sciences; Eurofins Advinus; GVRP and Veeda Clinical Research Limited are some of the other market participants in the India’s market.

• Sugen Life Sciences is a contract research organization focusing on toxicology, efficacy, pre-clinical safety, and clinical research services to research organizations and biopharma industries. International and national regulatory guidelines like EPA, FDA, Schedule Y, and ICH-GCP

• Eurofins Advinus is a preclinical CRO that offers preclinical and development-stage contract research services and drug discovery. Its services include Analytical R&D, CMC services, regulatory Toxicology, discovery services, and DMPK. The company manufactures medicinal products that support clinical and toxicology studies

Recent Developments

• In October 2023, Roche Products (India) Pvt. Ltd. announced the launch of its Indian clinical trial excellence project to improve public health institutions' capacity to conduct clinical trials and drug research nationwide. As a result, these government hospitals will be able to advance up the value chain and establish themselves as the nation's centers of excellence for clinical research

• In December 2023, Syngene International announced that it had completed the acquisition of a multi-modal biologics manufacturing facility from Selis Biopharma Ltd. The acquisition will boost its biologics drug substance manufacturing capacity by 20,000 liters. The facility is equipped with a commercial-scale fill-finish unit, an essential component for the production of drug products

• In September 2023, Syneos Health announced a strategic alliance with Oracle. The companies aim to decrease the duration required for patient recruitment for clinical studies and enhance the variety of patient populations participating in medical research by utilizing components of Oracle's study startup solutions and the Oracle Cerner Learning Health Network (LHN)

• In May 2023, Aragen Life Sciences Ltd. and Far Biotech announced a partnership to advance preclinical initiatives in the field of neurodegeneration. Aragen will utilize its experimental discovery platform to help FAR Biotech reach an essential milestone in neurodegeneration with its small molecule program

• In April 2023, Medidata announced a partnership with Lambda Therapeutic Research Ltd. to consolidate and automate data management processes to improve clinical trial efficiency. The companies aim to provide advanced data for faster insights safely through the alliance

• In March 2023, Syneos Health announced a strategic partnership with KX. The partnership focuses on providing predictive analytics driven by data, artificial intelligence, and machine learning to help customers make complex healthcare decisions. The collaboration aims to increase the efficiency of clinical trials, reduce costs, and accelerate the time to market for life-changing therapies that benefit patients

India Preclinical CRO Market Report Scope

India Preclinical CRO Market Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the India preclinical CRO market report based on service, model type, and end-use.

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Bioanalysis and DMPK Studies

    • In vitro ADME

    • In-vivo PK

  • Toxicology testing

    • GLP

    • Non-GLP

  • Compound management

    • Process R&D

    • Custom Synthesis

    • Others

  • Chemistry

    • Medicinal Chemistry

    • Computation Chemistry

  • Safety Pharmacology

  • Others           

• Model Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Patient Derived Organoid (PDO) Model

  • Patient Derived Xenograft Model

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Biopharmaceutical Companies

  • Government And Academic Institutes

  • Medical Device Companies